Requirements for Clinical Trials: the Ministerial Decree of March 20, 2023 by the Ministry of Health
The Decree of March 20, 2023, concerning the requirements for facilities conducting clinical trials, is a significant regulation for the healthcare sector. It was published in the Official Gazette on June 14, 2023, and issued by the Ministry of Health with the aim of establishing criteria and necessary conditions for healthcare facilities intending to conduct clinical trials in compliance with Article 62 paragraph 7 of the Medical Device Regulation (MDR).
In which facilities can a clinical trial be conducted?
This decree states that the facilities conducting clinical trials must be suitable for this purpose and similar to those where the medical device under investigation is intended to be used. This is to ensure that clinical studies are conducted in appropriate environments and that the devices are tested in contexts similar to their intended actual use.
To select suitable facilities, the trial sponsor must verify that they possess documented expertise in the field of controlled clinical studies, supported by scientific publications, patents, or other evidence of a similar level. Additionally, it is necessary to demonstrate the established and documented use of medical devices of the same type and class as those subject to the investigation in clinical practice.
What requirements must the facilities comply with? It depends on the DM!
The specific requirements vary based on the risk class of the medical device in question:
- Class III devices or invasive devices of Class IIa and IIb can be subjected to clinical trials in various facilities, including public hospital companies, university hospital companies, and university polyclinics, as well as other public and private healthcare institutions. These facilities must also comply with specific characteristics defined in Ministerial Decree 70/2015 or other regional regulations.
- Class I devices and non-invasive devices of Class IIa and IIb can be subjected to clinical trials in the aforementioned facilities and also in specialized outpatient and multispecialty clinics of the National Health Service (NHS) companies and in territorial facilities defined in Ministerial Decree 77/2022.
To ensure compliance with the requirements, the legal representative of the facility must certify them through an official declaration, with the attached supporting documentation, and publish it on the institutional website of the Ministry of Health. Providing false information is punishable by law.
An interesting aspect of the decree is the reference to digital tools used to conduct clinical trials outside the main facility, such as “decentralized trials.” In this case, the facility managing the investigation must ensure adequate levels of quality and safety by implementing mechanisms for reporting and managing any adverse events that may occur outside the controlled environment of the main facility.
In conclusion, this decree is a significant step forward in ensuring the reliability and quality of clinical trials conducted in Italy and in facilitating the harmonization of national regulations with the MDR. The regulation aims to protect the health and safety of patients and promote research and innovation in the medical sector.
We design clinical studies for medical devices certified according to European Regulation 2017/745 MDR (Medical Device Regulation) and constantly collect market data to support the safety of our products